Defective Drugs and Drug Recalls

If a defective prescription drug has the potential to harm consumers, the Food and Drug Administration (FDA) is the regulatory body that issues a recall notice to the public. The purpose of the recall is to get the drug off the market as quickly as possible. Drug recalls can be voluntary by the drug manufacturer, at the FDA’s request or by an FDA order.

The FDA classifies drug recalls as Class 1, Class 2 or Class 3 recalls. The distinction between the classes is as follows:

A Class 1 recall means there is a reasonable probability that using the drug will cause serious adverse health consequences or death

A Class 2 recall means that using the drug may cause temporary or medical reversible adverse health consequences, or the probability of serious adverse health consequences is remote

A Class 3 recall means that using the drug is not likely to cause adverse health consequences

A lesser classification is a “market withdrawal,” which occurs for minor violations, such as tampering, without evidence of manufacturing defects. Market withdrawals are not subject to FDA legal action.

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